Abstract
ABSTRACT We present the rationale and study design of the phase II trial of carboplatin plus S-1 plus gefitinib followed by S-1 plus gefitinib, which the multicenter trial on safety and efficacy of first-line therapies in advanced non-small cell lung cancer (NSCLC) patients harboring activating mutation of the EGFR gene. Treatment consists of up to 4 cycles of induction therapy followed by maintenance therapy until disease progression or treatment discontinuation in 28 patients. The primary end points of the present study are the efficacy objectives are to assess the 1 year progression free survival rate, the overall survival (OS), response rates, progression-free survival (PFS). In addition, safety will be investigated in the present study. If the primary objective (1 year progression free survival rate) is achieved and this treatment has good tolerability, this study will provide robust results on an alternative treatment option, carboplatin plus S-1 plus gefitinib followed by maintenance therapy with S-1 plus gefitinib, for patients with advanced nonsquamous NSCLC harboring activating mutation of the EGFR gene.
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